510(k) K201458

Scrambler Therapy Technology (Model ST-5A) by Delta International Services & Logistics S.R.L — Product Code GZJ

K201458 is an FDA 510(k) premarket notification submitted by Delta International Services & Logistics S.R.L for the device "Scrambler Therapy Technology (Model ST-5A)". The FDA issued a decision of Substantially Equivalent on Dec 23, 2020. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Delta International Services & Logistics S.R.L has at least 1 other 510(k) clearance on record.